Clomicalm: Product Information (Page 4 of 4)

Storage Conditions:

Store in a dry place at controlled room temperature, between 59° and 77°F (15-25°C). Store unused tablets in the original closed container.

How Supplied:

CLOMICALM Tablets are available in 5, 20, 40 and 80 mg tablet strengths in color-coded packaging for oral administration to dogs.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured for: Elanco US Inc., Greenfield, IN 46140, USA

Approved by FDA under NADA # 141-120.

Clomicalm, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

Principal Display Panel – 5 mg Carton Label

CLOMICALM™

(clomipramine hydrochloride)

5 mg

FOR USE IN DOGS ONLY

CLOMICALM Tablets are to be used as part
of a comprehensive behavioral
management program to treat separation
anxiety in dogs greater than 6 months
of age.

CAUTION:

Federal (USA) law restricts this drug for use
by or on the order of a licensed
veterinarian

Recommended
for dogs2.75-10.9 lbs.

body weight

Principal Display Panel – 5 mg Carton Label
(click image for full-size original)

Principal Display Panel – 5 mg Bottle Label

CLOMICALM™

(clomipramine hydrochloride)

5 mg (2.75-10.9 lbs. body weight)

FOR USE IN DOGS ONLY

CAUTION: Federal (USA) law restricts
this drug for use by or on the order ofa licensed veterinarian.

Net contents: 30 tablets

5 mg each

Product #611048

Principal Display Panel – 5 mg Bottle Label
(click image for full-size original)

Principal Display Panel – 20 mg Carton Label

CLOMICALM™

(clomipramine hydrochloride)

20 mg

FOR USE IN DOGS ONLY

CLOMICALM Tablets are to be used as part
of a comprehensive behavioral
management program to treat separation
anxiety in dogs greater than 6 months
of age.

CAUTION:

Federal (USA) law restricts this drug for use
by or on the order of a licensed
veterinarian

Recommended
for dogs11-22 lbs.

body weight

Principal Display Panel – 20 mg Carton Label
(click image for full-size original)

Principal Display Panel – 20 mg Bottle Label

CLOMICALM™

(clomipramine hydrochloride)

20 mg (11-22 lbs. body weight)

FOR USE IN DOGS ONLY

CAUTION: Federal (USA) law restricts
this drug for use by or on the order ofa licensed veterinarian.

Net contents: 30 tablets

20 mg each

Product #611049

Principal Display Panel – 20 mg Bottle Label
(click image for full-size original)

Principal Display Panel – 80 mg Carton Label

CLOMICALM™

(clomipramine hydrochloride)

80 mg

FOR USE IN DOGS ONLY

CLOMICALM Tablets are to be used as part
of a comprehensive behavioral
management program to treat separation
anxiety in dogs greater than 6 months
of age.

CAUTION:

Federal (USA) law restricts this drug for use
by or on the order of a licensed
veterinarian

Recommended
for dogs44.1-176 lbs.

body weight

Principal Display Panel – 80 mg Carton Label
(click image for full-size original)

Principal Display Panel – 80 mg Bottle Label

CLOMICALM™

(clomipramine hydrochloride)

80 mg (44.1 -176 lbs. body weight)

FOR USE IN DOGS ONLY

CAUTION: Federal (USA) law restricts
this drug for use by or on the order ofa licensed veterinarian.

Net contents: 30 tablets

80 mg each

Product #611049

Principal Display Panel – 80 mg Bottle Label
(click image for full-size original)
CLOMICALM clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-4030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
Lactose, Unspecified Form
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
POVIDONE K30
Silicon dioxide
Magnesium Palmitostearate
Product Characteristics
Color brown (Brown) Score 2 pieces
Shape OVAL (OVAL) Size 9mm
Flavor MEAT (MEAT) Imprint Code DV;CG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-4030-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (58198-4030-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141120 11/22/2006
CLOMICALM clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-4935
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
Lactose, Unspecified Form
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
POVIDONE K30
Silicon dioxide
Magnesium Palmitostearate
Product Characteristics
Color brown (Brown) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor MEAT (MEAT) Imprint Code GN;CG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-4935-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (58198-4935-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141120 12/10/1998
CLOMICALM clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-4940
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 80 mg
Inactive Ingredients
Ingredient Name Strength
Lactose, Unspecified Form
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
POVIDONE K30
Silicon dioxide
Magnesium Palmitostearate
Product Characteristics
Color brown (Brown) Score 2 pieces
Shape OVAL (OVAL) Size 15mm
Flavor MEAT (MEAT) Imprint Code CG;CG;CV;CV
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-4940-3 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (58198-4940-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141120 12/10/1998
Labeler — Elanco US Inc. (966985624)

Revised: 09/2019 Elanco US Inc.

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